Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 407-410-2 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.47 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 110.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No long-term study on inhalation is available. Thus route-to-route extrapolation has been performed. No data are available that would indicate a specific concern for the inhalation route that would invalidate this approach.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Difference in duration subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable (accounted for by respiratory volumes)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default for worker
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.42 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No dermal long-term study is available. Thus route-to-route extrapolation has been performed. No data are available that would indicate a specific concern for the dermal route that would invalidate this approach.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Difference in duration subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (rat)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default (worker)
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Repeated dose toxicity/systemic effects:
The basis for deriving systemic long-term DNELs is a 28 day oral toxicity study in Wistar rats (Schladt, 1991).
Adverse effects were reported for body weight gain in the 625 mg/kg bw male dose group. In the 625 mg/kg bw dose group significant haematological effects were observed, and increased liver weights together with hypertrophy of hepatocytes were noted for both female and male rats.
The NOAEL is 125 mg/kg/d.
No data are available that would indicate a specific concern for the inhalation and dermal route. Thus, route-to-route extrapolation is justified. ECHA guidance values were used to account for possible differences in route-specific absorption rates (dermal = oral and inhalation = 200 % oral).
The test item is considered not to exhibit any sensitising properties according to a guideline-compliant study under GLP in guinea pigs (Diesing, 1991).
Acute toxicity/local effects:
According to ECHA guidance there is no established accepted methodology to derive no-effect-levels for acute toxicity. Under these prerequisites derivation of acute DNELs is considered not only to be cumbersome and resource-intensive but probably unnecessary, as the long-term DNEL is normally sufficient to safeguard against any acute effects. It is proposed that a DNEL for acute toxicity should be derived only if an acute toxicity hazard (leading to C&L) is identified and there is a potential for high peak exposures. However, the test item is not classified for acute toxicity based on LD50 > 2000 mg/kg for the oral and dermal route (Bomhard, 1990/1991).
Data on skin irritation/corrosion and eye irritation in vivo suggest a low hazard potential with regard to local effects (Märtins, 1991).
Overall, a low hazard potential is concluded for the test item.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.36 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 54.35 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No long-term study on inhalation is available. Thus route-to-route extrapolation has been performed. No data are available that would indicate a specific concern for the inhalation route that would invalidate this approach.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Difference in duration subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable (accounted for by respiratory volumes)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default for general population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.21 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No dermal long-term study is available. Thus route-to-route extrapolation has been performed. No data are available that would indicate a specific concern for the dermal route that would invalidate this approach.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Difference in duration subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (rat)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default for general population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Repeated dose toxicity/systemic effects:
The basis for deriving systemic long-term DNELs is a 28 day oral toxicity study in Wistar rats (Schladt, 1991).
Adverse effects were reported for body weight gain in the 625 mg/kg bw male dose group. In the 625 mg/kg bw dose group significant haematological effects were observed, and increased liver weights together with hypertrophy of hepatocytes were noted for both female and male rats.
The NOAEL is 125 mg/kg/d.
No data are available that would indicate a specific concern for the inhalation and dermal route. Thus, route-to-route extrapolation is justified. ECHA guidance values were used to account for possible differences in route-specific absorption rates (dermal = oral and inhalation = 200 % oral).
The test item is considered not to exhibit any sensitising properties according to a guideline-compliant study under GLP in guinea pigs (Diesing, 1991).
Acute toxicity/local effects:
According to ECHA guidance there is no established accepted methodology to derive no-effect-levels for acute toxicity. Under these prerequisites derivation of acute DNELs is considered not only to be cumbersome and resource-intensive but probably unnecessary, as the long-term DNEL is normally sufficient to safeguard against any acute effects. It is proposed that a DNEL for acute toxicity should be derived only if an acute toxicity hazard (leading to C&L) is identified and there is a potential for high peak exposures. However, the test item is not classified for acute toxicity based on LD50 > 2000 mg/kg for the oral and dermal route (Bomhard, 1990/1991).
Data on skin irritation/corrosion and eye irritation in vivo suggest a low hazard potential with regard to local effects (Märtins, 1991).
Overall, a low hazard potential is concluded for the test item.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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